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The pros and cons of Prolia, Amgen's new osteoporosis drug

June 14, 2010

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RATING:

Overall a well done and informative story - although it did not always use the absolute risk/benefit statistics that we prefer.

Our Review Summary

The story detailed what is known about the impact of this drug on various types of bone fractures associated with osteoporosis, how its mode of action is someone different than other osteoporosis treatments, its administration and how the costs compare with other treatments.  The one shortcoming of the story was that it had elements of disease-mongering, as explained below.


Why This Matters:

 The gestalt about osteoporosis is that women should live in fear of bone breaks. While the story provided very good information about this new treatment, it did not provide much context about the problem. And its inconsistent use of relative vs. absolute risk/benefit data didn't help.

 

Click on Criteria for definitions.

 The story opens with a statement about this drug's approval by the FDA.

Checkmark
Discuss costs? - SATISFACTORY

 This story not only mentions the cost for this drug but also for other treatments for osteoporosis as well.

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Avoid "disease-mongering"? - NOT SATISFACTORY

The story only indicated lifetime risks of fracture (i.e. 1 out of every 2 women over the age of 50) and that 25% of people die within 5 years of breaking a hip without providing some context for these concerns.  The 5 year risk of fracture for a woman aged 55 is not the same as that for a woman aged 75; similarly, there are other factors compounding the statistic about death following hip fracture.  

Since the drug is marketed as being for women who are postmenopausal, rather than simply parroting these seemingly alarming pieces of information, the story should have provided more context for these statistics.

This was one weak point in an overall strong story - but an important nuance that should not be overlooked.

The story provided information about the clinical trial it described, including the number of people studied, the length of time they were studied and the impact on various types of fractures.

The story gave a rather complete listing of the potential harms associated with the use of this drug, including specific mention of those problems that are unique to this drug as compared with other medications used to manage bone loss.  Although the list was complete, the story did not indicate the frequency with which these harms occurred. Nonethless, we'll give the story the benefit of the doubt on this criterion.

 The story provided a useful explanation of how this medication differed from the other treatments available for osteoporosis.

 The story did a great job of distinguishing among various fracture types and reporting both relative and absolute risk reduction for vertebra fracture. But then it was disappointing that the risk reduction for hip fractures and that of wrist, leg, or shoulder were reported as only relative risk reduction.  Since the story characterized hip fractures as 'devastating', it should have provided the reader with some sense of how frequently they occur rather than simply indicating how often they result in a person entering a nursing home or dying within 5 years of having one. Nonethless, because of the elements that were well done, we'll give the story the benefit of the doubt on this criterion.

 Does not appear to rely exclusively on a news release.

 Comments about this drug and its potential utility from two clinicians noted as not having industry ties to this or other osteoporosis drugs were included in this story.

 This story compared the benefits, harms and costs for the new drug, with those treatments already on the market.

Total Score: 9 of 10 Satisfactory

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